Question

Validation is defined as

• A. Calibration of instruments
• B. Verification of supplier
• C. Documented evidence that a process consistently produces expected results
• D. Training of personnel

Hint:

In pharmaceutical quality systems, validation is a formal, documented activity.

Answer 1

The Correct Option is C

Concept:
In pharmaceutical quality systems, validation is a formal, documented activity. It means establishing documented evidence which provides a high degree of assurance that a specific process, method or system will consistently produce a result meeting its predetermined specifications.

Step 1: Notice the key words in the definition: "documented evidence" and "consistently produces expected results." This matches option 3 exactly.

Step 2: The other choices describe related but different activities. Calibration of instruments is about checking measuring equipment against a standard. Verification of a supplier is part of vendor qualification. Training of personnel is part of human resource management. None of these is the definition of validation.

Answer: Option (3) — Validation is documented evidence that a process consistently produces expected results. (3)